Abstract

Agency officials continue to consider the safety and efficacy of over-thecounter cold and cough products for children aged 2 to 11 years, and whether regulatory actions regarding these products should be taken. Among the considerations are whether products targeting children aged 2 to 5 years should be removed from the market or their labels revised, as well as how to prevent caregivers from giving liquid medicines intended for older children to younger ones, according to Ganley. In the meantime, while the agency weighs issues related to the use of overthe-counter cold and cough products in children aged 2 years and older, parents who choose to use these drugs in older children should take several precautions to prevent overdose, said Lisa Mathis, MD, associate director of the Office of New Drugs, Pediatric and Maternal Health Staff in the FDA’s Center for Drug Evaluation and Research. Such precautions include • Reading the labels and taking note of the active ingredients. Many products have the same ingredients and giving a child more than one product may result in an inadvertent overdose. • Measuring doses using only dosing cups or spoons provided with the medication or those specially designed for administering drugs because household spoons vary in size and may lead to an incorrect dose. • Using products with childproof caps and storing them out of children’s’ reach. • Consulting a physician or other clinician about any questions concerning the use of these drugs in children aged 2 years or older. More information about the FDA’s recommendations are available online (http://www.fda.gov/cder/drug/advisory /cough_cold_2008.htm), as well as information for consumers (http://www .fda.gov/consumer/updates/coughcold011708.html).

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